Unannounced US FDA inspection concludes with Zero 483 at Lambda’s Ahmedabad Facility
May 2, 2026
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NEWS
Transdermal and Topical Products: Early Phase BA BE Study Capabilities
April 28, 2026
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Lambda conducts early phase BA/BE studies for transdermal and topical products with a focus on pharmacokinetics, adhesion performance, and skin safety. Experience spans multiple molecules and dosage forms, supported by controlled application techniques and consistent study execution.
CAP Accreditation Extended till 01 March 2028, Marking Continuous Compliance Since 2005
April 16, 2026
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NEWS
Accelerated Study Start for BA/BE Programs in India with CDSCO Prior Intimation Pathway (CT-05)
April 15, 2026
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The regulatory environment in 2025 was defined by consolidation, clarification, and higher expectations for execution. Across major regions, regulators focused on improving trial quality, reducing avoidable administrative burden, and enabling scientific progress while maintaining patient safety and data integrity.
FDA Launches Framework to Accelerate Individualized Therapies for Ultra-Rare Diseases
February 28, 2026
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The agency’s new “Plausible Mechanism Framework” creates a first-of-its-kind regulatory pathway for genome editing and RNA-based therapies targeting small patient populations where traditional clinical trials
Patient-Centric Trials in Advancing Cancer Research: A Journey of Progress & Hope
February 4, 2026
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On World Cancer Day, we recognize the importance of cancer research in expanding early access to investigational therapies and generating evidence that informs progress in